NCT06833671

Brief Summary

This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.4 years

First QC Date

February 13, 2025

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein (CRP) level

    C-reactive protein (CRP) level was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.

    4 hours postoperatively

Secondary Outcomes (7)

  • Neutrophil/ lymphocyte ratio

    4 hours postoperatively

  • Level of procalcitonin

    4 hours postoperatively

  • Homeostatic model assessment for insulin resistance

    4 hours postoperatively

  • Level of C-peptide

    4 hours postoperatively

  • Level of random blood glucose

    Two hours before the surgery

  • +2 more secondary outcomes

Study Arms (3)

Apple juice group

EXPERIMENTAL

A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).

Other: Apple juice

Anhydrous glucose group

EXPERIMENTAL

A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).

Drug: Anhydrous glucose

Water group

OTHER

Patients received water

Other: Water

Interventions

A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).

Apple juice group

A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).

Anhydrous glucose group
WaterOTHER

Patients received water.

Water group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age from 5 to 10 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Scheduled for elective surgery.

You may not qualify if:

  • Diabetes mellitus.
  • Insulin resistance (IR).
  • Renal or hepatic insufficiency.
  • Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

  • Abdelwahed WMA, Abdelelsalam WM, Taha OA, Abdelbadie S, Taleb AMA. Effect of Preoperative 2-Hour Carbohydrate Load on Pediatric Patients Undergoing Elective Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2025 Dec 3;2025:5580879. doi: 10.1155/anrp/5580879. eCollection 2025.

MeSH Terms

Interventions

GlucoseWater

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 19, 2025

Study Start

June 1, 2022

Primary Completion

October 21, 2024

Study Completion

October 21, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations